BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESHEATH SLENDER

    MDR report key: 7178444 · Received January 10, 2018

    Report

    Report Number
    9681834-2017-00273
    Event Type
    Injury
    Date Received
    January 10, 2018
    Report Date
    January 10, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DYB
    UDI-DI
    04987350718068
    PMA / PMN Number
    K142183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS UNABLE TO BE CONDUCTED DUE TO THE UNKNOWN LOT NUMBER. THE SAME USER FACILITY REPORTED SIMILAR EVENTS. THIS REPORT IS FOR THE SECOND DEVICE, SEE MDRS: 9681834-2017-00272 AND 9681834-2017-00274 FOR THE FIRST AND THIRD DEVICE. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. IFU FOR THIS PRODUCT HAS THE INSTRUCTIONS AS FOLLOWS: ADVANCE OR WITHDRAW THE MINI GUIDE WIRE SLOWLY. IF RESISTANCE IS MET, DO NOT ADVANCE OR WITHDRAW THE MINI GUIDE WIRE UNTIL THE CAUSE OF RESISTANCE IS DETERMINED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THEY USED TO USE 20-1060 AND SWITCHED TO THE SLENDER. THEY BELIEVE THE .021" WIRE IN THE SLENDER KIT IS STIFFER. THEY HAVE EXPERIENCED A FEW PSEUDO ANEURYSMS IN THE PAST MONTHS AND ATTRIBUTE IT TO THE STIFFER WIRE OR THE VASC BAND. ALL OF THE PATIENTS RECOVERED AND NO SURGERY WAS NEEDED. THE PROCEDURE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23563 GLIDESHEATH SLENDER INTRODUCER, CATHETER DYB TERUMO CORPORATION, ASHITAKA N/A 04987350718068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other